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Phase 1 Clinical Trial of Trametes versicolor in Women with Breast Cancer.

Torkelson CJ, Sweet E, Martzen MR, Sasagawa M, Wenner CA, Gay J, Putiri A, Standish LJ - ISRN Oncol (2012)

Bottom Line: Nine adverse events were reported (7 mild, 1 moderate, and 1 severe), suggesting that Tv was well tolerated.Immunological results indicated trends in (1) increased lymphocyte counts at 6 and 9 grams/day; (2) increased natural killer cell functional activity at 6 grams/day; (3) dose-related increases in CD8(+) T cells and CD19(+) B cells , but not CD4(+) T cells or CD16(+)56(+) NK cells.Conclusion.

View Article: PubMed Central - PubMed

Affiliation: Department of Family Medicine and Community Health, Medical School, University of Minnesota, 420 Delaware Street SE, MMC 381, Mayo Building B529, Minneapolis, MN 55455, USA.

ABSTRACT
Introduction. Orally administered preparations from the Trametes versicolor (Tv) mushroom have been hypothesized to improve immune response in women with breast cancer after standard chemotherapy and radiotherapy. Methods. A phase I, two-center, dose escalation study was done to determine the maximum tolerated dose of a Tv preparation when taken daily in divided doses for 6 weeks after recent completion of radiotherapy. Eleven participants were recruited and nine women completed the study. Each cohort was comprised of three participants given one of three doses of Tv (3, 6, or 9 grams). Immune data was collected pre- and postradiation, at 3 on-treatment time points and after a 3-week washout. Results. Nine adverse events were reported (7 mild, 1 moderate, and 1 severe), suggesting that Tv was well tolerated. Immunological results indicated trends in (1) increased lymphocyte counts at 6 and 9 grams/day; (2) increased natural killer cell functional activity at 6 grams/day; (3) dose-related increases in CD8(+) T cells and CD19(+) B cells , but not CD4(+) T cells or CD16(+)56(+) NK cells. Conclusion. These findings show that up to 9 grams/day of a Tv preparation is safe and tolerable in women with breast cancer in the postprimary treatment setting. This Tv preparation may improve immune status in immunocompromised breast cancer patients following standard primary oncologic treatment.

No MeSH data available.


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Mentions: The red blood cell compartment was unaffected by both Radiation Therapy (RT) and Tv administration. Absolute red blood cell count, hemoglobin, and hematocrit were normal at visit one, which was the day before RT began, and continued to fall within normal limits throughout the rest of the study. Absolute white blood cell count and neutrophil counts were generally within normal limits for all women both before and after RT and during the weeks after RT while they were taking Tv (data not shown). However, absolute lymphocyte counts revealed a different pattern from the other CBC subsets. As eligibility criteria were identical in studies conducted by our centers since 2006, in order to increase power, we combined the data from our observational study (N = 14) that showed that RT produced immune defects in women with stage I–III breast cancer [16] with our current dose escalation study (N = 9). For the combined number of 23 women in both studies with stage I–III breast cancer status after breast surgery and chemotherapy who then received radiotherapy, lymphocytes were within normal limits before RT but dropped to abnormally low levels after RT. The mean lymphocyte count for all 23 subjects before RT was 1.027 ± 0.298 and dropped 20% after RT to 0.681 ± 0.254, a difference which was statistically significant [t(44) = 4.236, P < 0.001]. In the dose escalation study, the two higher oral doses (6 and 9 g) of Tv resulted in an earlier recovery of lymphocyte counts (Figure 2). The number of lymphocytes gradually recovered for the observational group, but the mean lymphocyte counts remained below those for the 6 and 9 gm Tv cohorts at 6 weeks following RT. Due to the small number for each dose cohort (N = 3), statistical significance was found only between the observational and 9 g groups at the 2-week postradiotherapy time point. Radiation therapy statistically significantly depressed the absolute number of lymphocytes in women with stage I–III breast cancer who have completed surgery and chemotherapy (see Figure 2).


Phase 1 Clinical Trial of Trametes versicolor in Women with Breast Cancer.

Torkelson CJ, Sweet E, Martzen MR, Sasagawa M, Wenner CA, Gay J, Putiri A, Standish LJ - ISRN Oncol (2012)

© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3369477&req=5

Mentions: The red blood cell compartment was unaffected by both Radiation Therapy (RT) and Tv administration. Absolute red blood cell count, hemoglobin, and hematocrit were normal at visit one, which was the day before RT began, and continued to fall within normal limits throughout the rest of the study. Absolute white blood cell count and neutrophil counts were generally within normal limits for all women both before and after RT and during the weeks after RT while they were taking Tv (data not shown). However, absolute lymphocyte counts revealed a different pattern from the other CBC subsets. As eligibility criteria were identical in studies conducted by our centers since 2006, in order to increase power, we combined the data from our observational study (N = 14) that showed that RT produced immune defects in women with stage I–III breast cancer [16] with our current dose escalation study (N = 9). For the combined number of 23 women in both studies with stage I–III breast cancer status after breast surgery and chemotherapy who then received radiotherapy, lymphocytes were within normal limits before RT but dropped to abnormally low levels after RT. The mean lymphocyte count for all 23 subjects before RT was 1.027 ± 0.298 and dropped 20% after RT to 0.681 ± 0.254, a difference which was statistically significant [t(44) = 4.236, P < 0.001]. In the dose escalation study, the two higher oral doses (6 and 9 g) of Tv resulted in an earlier recovery of lymphocyte counts (Figure 2). The number of lymphocytes gradually recovered for the observational group, but the mean lymphocyte counts remained below those for the 6 and 9 gm Tv cohorts at 6 weeks following RT. Due to the small number for each dose cohort (N = 3), statistical significance was found only between the observational and 9 g groups at the 2-week postradiotherapy time point. Radiation therapy statistically significantly depressed the absolute number of lymphocytes in women with stage I–III breast cancer who have completed surgery and chemotherapy (see Figure 2).

Bottom Line: Nine adverse events were reported (7 mild, 1 moderate, and 1 severe), suggesting that Tv was well tolerated.Immunological results indicated trends in (1) increased lymphocyte counts at 6 and 9 grams/day; (2) increased natural killer cell functional activity at 6 grams/day; (3) dose-related increases in CD8(+) T cells and CD19(+) B cells , but not CD4(+) T cells or CD16(+)56(+) NK cells.Conclusion.

View Article: PubMed Central - PubMed

Affiliation: Department of Family Medicine and Community Health, Medical School, University of Minnesota, 420 Delaware Street SE, MMC 381, Mayo Building B529, Minneapolis, MN 55455, USA.

ABSTRACT
Introduction. Orally administered preparations from the Trametes versicolor (Tv) mushroom have been hypothesized to improve immune response in women with breast cancer after standard chemotherapy and radiotherapy. Methods. A phase I, two-center, dose escalation study was done to determine the maximum tolerated dose of a Tv preparation when taken daily in divided doses for 6 weeks after recent completion of radiotherapy. Eleven participants were recruited and nine women completed the study. Each cohort was comprised of three participants given one of three doses of Tv (3, 6, or 9 grams). Immune data was collected pre- and postradiation, at 3 on-treatment time points and after a 3-week washout. Results. Nine adverse events were reported (7 mild, 1 moderate, and 1 severe), suggesting that Tv was well tolerated. Immunological results indicated trends in (1) increased lymphocyte counts at 6 and 9 grams/day; (2) increased natural killer cell functional activity at 6 grams/day; (3) dose-related increases in CD8(+) T cells and CD19(+) B cells , but not CD4(+) T cells or CD16(+)56(+) NK cells. Conclusion. These findings show that up to 9 grams/day of a Tv preparation is safe and tolerable in women with breast cancer in the postprimary treatment setting. This Tv preparation may improve immune status in immunocompromised breast cancer patients following standard primary oncologic treatment.

No MeSH data available.


Related in: MedlinePlus